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RecruitingNCT07511816Updated May 1, 2026

A Study of LY4515100 in Participants With Pain Following Third Molar Removal

A Phase 2 interventional study of LY4515100 and Placebo in Acute Pain, Molar and Molar, Third, sponsored by Eli Lilly and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain after removing impacted third molars. For each participant, the study may last approximately 6 weeks and will include a stay in a Clinical Research Unit (CRU) after third molar removal.

02

Conditions studied

  • Acute Pain
  • Molar
  • Molar, Third
  • Surgery, Oral

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03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's planned enrollment of 212 is above the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive.
  • Participant requires extraction of 2 or more third molars, including 2 mandibular molars with partial or full bony impaction, confirmed by panoramic X-ray.

Exclusion criteria

Exclusion Criteria:

  • Prior dental surgery within 60 days before screening or history of other surgical procedures that could confound surgery or postoperative procedures.
  • Diagnosis of chronic pain conditions that could confound postsurgical pain reporting in the opinion of the investigator.
  • Positive urine drug screen or alcohol test during screening or on the day of surgery.
  • Evidence or history of any other clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases, in the opinion of the investigator, within the last 5 years.
  • History of malignancy of any organ system treated or untreated, within 5 years prior to consent. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell carcinoma of the skin, or localized squamous carcinoma of the skin if the participant has been treated and is considered cured.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
212 participants (estimated)

Study arms

  • Experimental
    LY4515100

    Administered Orally

    Drug: LY4515100

  • Placebo comparator
    Placebo

    Administered Orally

    Drug: Placebo

Interventions

  • DrugLY4515100

    Administered Orally

  • DrugPlacebo

    Administered Orally

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Self-Reported Pain Intensity

    Time frame: Baseline, Up to Day 1

Secondary outcomes

  1. Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale

    Time frame: Baseline, Up to Day 1

  2. Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale

    Time frame: Baseline, Up to Day 1

  3. Time to Rescue Medications

    Time frame: Baseline, Up to Day 1

  4. Participants Overall Impression of Pain Relief on a Five-Point Scale

    Time frame: Baseline, Up to Day 1

  5. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100

    Time frame: Baseline, Up to Day 1

07

Study locations

1 of 1 sites recruiting
  • JBR Clinical Research
    Salt Lake City, Utah 84107, United States
    • Todd Bertoch · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07511816
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 6, 2026
Start date
Apr 1, 2026
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 1, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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